Link two-section form data

Study designers can now add a Link & Show Form rule to either or both sections of a two-section form and this form type can be both the source and the target of the association.

Site users can now link two-section form data, further enhancing Oracle Clinical One Platform's ability to recognize relationships between collected data. For example, site users can link data from a two-section form with other data from other repeating and two-section forms for the purpose of collecting relationships between medical history and medication data. Associating the information on two-section forms can make it easier to recognize possible relationships between all types of collected data, including study drugs, adverse reactions and concomitant medications, and the evaluation of target lesions.

These associations can be made in the same way as existing repeating form associations, via a question, from or to the two-section forms to provide cross-references between the form instances or individual rows of repeating data. In this way, when users display the details of one associated form, they can easily view the details of any instances of the other associated form.

If your study is set up with this feature, when the site user answers the question that creates the association, a window appears directly below the question. It is in this window where the user is presented options to create the correct links. A form can have zero-to-many associations, for example, an instance of concomitant medication can be linked to an adverse event and also to a medical condition.

Note:

Only two-section and simple repeating forms are allowed to be the source of an association. Flat forms, however, can be the target of an association. In this way, a user could link data from a flat form (for example, vital signs) back to a two-section or repeating form.

Details for study designers

If you need to allow site users to link two-section form data, you must know that you can now create form associations for either sections (Questions Before the Table or Questions in the Table) for a two-section form. You can configure two-section form associations by using the Link & Show Form predefined rule.

You can find additional information in the Study Designer User Guide after the Release Assessment Environment (RAE) upgrade.

Details for site users

If you need to link forms, here's what's new for you:

• When you make an answer selection that determines whether the rule will show the associated form, a window appears which contains all possible instances of forms or records that have been associated in study design.

  Note:

  Data must be entered in the linked form for it to appear in the associated form window. If data has not yet been entered, it can be linked after data entry is complete.
• A new filter appears, prompting you to link the forms depending on the form and visit. An additional Form Instance filter is displayed if the target of the form association is a two-section form.
• A Hide or Show feature appears in the form window to either collapse or expand the associated form. When compressing the form, users can see a short summary of the links created.
• When a two-section form is the target, it displays three drop-down options to: Select a Form, Visit/ Event, and Form Instance. When the repeating and flat forms are the target, it will show two filters: Design Form and Visit.
• The Associated Forms drop-down displays all of the forms that you can link to the form that you're currently in (for example: repeating form, two-section form, and flat forms).
• If more than one form is available to be linked to the parent form, then forms are displayed in alphabetical order in the Associated Forms drop-down.
• If a flat form is being linked then the only option for associating data is to turn the Link all data toggle on.
• If a two-section form is being linked, then you have the option of linking both the flat and repeating section of form by turning the Link all data toggle on, or you can choose to link a specific row or specific rows, only.

You can find additional information in the Site User Guide after the Release Assessment Environment (RAE) upgrade.

Figure 6-1 How a site user sees the new updates for linking two-section forms

Already working in a live study?

As soon as the release upgrade completes, as a study designer, you can begin creating form associations for two-section forms. After you update the study's design and the sponsor team tests and moves the updated study version to Testing and Approved, a site user can begin linking two-section forms.